# K242066: iSage Rx

- Pathway: 510(k) (Traditional)
- Applicant: Amalgam Rx, Inc.
- Decided: Aug 21, 2024 after 37 days
- Product code: NDC (Calculator, Drug Dose)
- Device class: 2
- Regulation: 21 CFR 868.1890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K161865 (2017). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161865: iSage Rx (iSage Rx Basal Insulin Titration), Isag Rx, Inc. (2017) Summary page 4.

## Indications for use
iISage Rx is indicated for use by adult patients with type 2 diabetes, and by their healthcare providers to provide ongoing support for understanding and following a titration plan for the following medications, with the goal of reaching optimal medication dose and/or target fasting blood sugar control: -Basal insulins -Combinations of basal insulin and GLP-1 receptor agonists

Source page: https://510kreport.com/device/K242066
Methodology: https://510kreport.com/methodology